ID

21049

Descripción

DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00330369

Link

https://clinicaltrials.gov/show/NCT00330369

Palabras clave

Versiones (1)
  1. 6/4/17 6/4/17 -
Subido en

6 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT00330369

Inglés

Eligibility Hypertension NCT00330369

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who are competent to provide written consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
aged 35 to 80 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
Descripción

Diabetes Mellitus | Chronic Kidney Diseases | Systolic Pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C1561643
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0444504
all other subjects must have a mean systolic blood pressure ≥140 mmhg
Descripción

Study Subject Systolic Pressure mean

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0444504
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
Descripción

Antihypertensive Agents Class Different Quantity | Diuretic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C1705242
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0012798
female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
Descripción

Gender Childbearing Potential Absent | Postmenopausal state | Female Sterilization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg
Descripción

Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C1510992
serum alt or ast >2 x the upper limit of the normal range (uln)
Descripción

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (cva) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
Descripción

Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0264906
UMLS CUI [6]
C0151517
UMLS CUI [7]
C0004238
UMLS CUI [8,1]
C0080203
UMLS CUI [8,2]
C0018792
UMLS CUI [8,3]
C2945760
UMLS CUI [9]
C1737264
UMLS CUI [10]
C0741627
implanted pacemakers or implanted cardioverter defibrillator (icd)
Descripción

pacemaker implant | Implantable defibrillator

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0848753
UMLS CUI [2]
C0162589
symptomatic congestive heart failure requiring treatment
Descripción

Symptomatic congestive heart failure Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C0332121
hemodynamically significant valvular heart disease
Descripción

Heart valve disease Hemodynamic Significant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0019010
UMLS CUI [1,3]
C0750502
type i diabetes mellitus
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
hemodialysis or peritoneal dialysis; or history of renal transplant
Descripción

Hemodialysis | Peritoneal Dialysis | Kidney Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0031139
UMLS CUI [3]
C0022671
diagnosis or recurrence of malignancy within the past 3 years
Descripción

Malignant Neoplasm | Recurrent tumor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0521158
sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
Descripción

Sleep Apnea | Arterial oxygen saturation measurement Sleep study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2,1]
C0428175
UMLS CUI [2,2]
C0162701
subjects who perform alternating shift or night work
Descripción

Shift worker | Night work

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0425104
UMLS CUI [2]
C1659095
subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to screening
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Hypertension NCT00330369

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subjects who are competent to provide written consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged 35 to 80 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus | Chronic Kidney Diseases | Systolic Pressure mean
Item
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
boolean
C0011849 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Study Subject Systolic Pressure mean
Item
all other subjects must have a mean systolic blood pressure ≥140 mmhg
boolean
C0681850 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
Antihypertensive Agents Class Different Quantity | Diuretic
Item
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
boolean
C0003364 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1705242 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0012798 (UMLS CUI [2])
Gender Childbearing Potential Absent | Postmenopausal state | Female Sterilization
Item
female subjects of non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average
Item
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
serum alt or ast >2 x the upper limit of the normal range (uln)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Atrial Fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC
Item
subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (cva) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0004238 (UMLS CUI [7])
C0080203 (UMLS CUI [8,1])
C0018792 (UMLS CUI [8,2])
C2945760 (UMLS CUI [8,3])
C1737264 (UMLS CUI [9])
C0741627 (UMLS CUI [10])
pacemaker implant | Implantable defibrillator
Item
implanted pacemakers or implanted cardioverter defibrillator (icd)
boolean
C0848753 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
Symptomatic congestive heart failure Treatment required for
Item
symptomatic congestive heart failure requiring treatment
boolean
C0742758 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Heart valve disease Hemodynamic Significant
Item
hemodynamically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Hemodialysis | Peritoneal Dialysis | Kidney Transplantation
Item
hemodialysis or peritoneal dialysis; or history of renal transplant
boolean
C0019004 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Malignant Neoplasm | Recurrent tumor
Item
diagnosis or recurrence of malignancy within the past 3 years
boolean
C0006826 (UMLS CUI [1])
C0521158 (UMLS CUI [2])
Sleep Apnea | Arterial oxygen saturation measurement Sleep study
Item
sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation greater than or equal to 90%
boolean
C0037315 (UMLS CUI [1])
C0428175 (UMLS CUI [2,1])
C0162701 (UMLS CUI [2,2])
Shift worker | Night work
Item
subjects who perform alternating shift or night work
boolean
C0425104 (UMLS CUI [1])
C1659095 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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